Classification
Product TypeIngredient
Product FormPowder
Industry PositionFood Additive / Food Ingredient
Market
Calcium gluconate (INS 578) is recognized in India’s food additive framework as an acidity regulator and firming agent, and its use is food-category specific under FSSAI’s notified standards. India participates in two-way trade for the broader HS 291816 group (gluconic acid, its salts and esters), importing significant volumes largely from China while also exporting to markets including the EU and the United States. For imports into India, consignments are processed through Customs ICEGATE and FSSAI’s Food Import Clearance System (FICS) with document scrutiny, sampling, and testing before a No Objection Certificate (NOC) is issued. Commercially, calcium gluconate demand is primarily B2B, linked to processed food manufacturing where permitted, and to nutrient supplement use-cases recognized in international additive evaluations.
Market RoleTwo-way traded ingredient market (domestic demand with imports; also exports within HS 291816 group)
Domestic RoleB2B food-ingredient input used where permitted under FSSAI additive provisions
Specification
Physical Attributes- Typically supplied as a white to off-white crystalline powder or granules (buyer specification-dependent)
- Batch identity and traceability are commonly managed via lot/batch details and Certificate of Analysis (CoA) in the India import clearance workflow
Compositional Metrics- Conformance to applicable specifications for INS 578 (e.g., JECFA specifications where used as the reference specification set)
Grades- Food additive grade for use in categories/limits permitted under FSSAI regulations
- Buyer-specified grades may differ by end use; import clearance testing references submitted CoA for quality parameters
Packaging- Commonly shipped in moisture-protective industrial packs (e.g., lined bags/drums) aligned to import documentation and batch traceability needs
Supply Chain
Value Chain- Overseas manufacturer → export documents (incl. CoO/CoA as applicable) → sea/air freight → Indian port/ICD → Customs ICEGATE (BoE) + SWIFT referral → FSSAI FICS document scrutiny → visual inspection/sampling/testing → NOC (release) or NCR (non-conformance) → importer storage/distribution to B2B manufacturers
Shelf Life- Import clearance documentation references declared “Best before/expiry” context via balance shelf-life concepts and consignment handling requirements
Freight IntensityLow
Transport ModeMultimodal
Risks
Regulatory Compliance HighNon-conformance with applicable FSSAI standards (including whether INS 578 is permitted for the intended food category and whether testing aligns with declared quality parameters) can result in NCR issuance, rejection, and major supply disruption at port.Pre-validate intended use category under FSSAI additive provisions; align label/ingredient list and end-use declaration; submit a complete CoA matching relevant parameters and ensure importer licensing/IEC are valid before shipment.
Documentation Gap MediumMissing or inconsistent import documentation (e.g., BoE-linked filings, CoO, label/ingredient list, end-use declaration, or CoA where applicable) can trigger FICS queries, delays, or adverse outcomes in clearance.Use the FSSAI Food Imports Manual checklist for mandatory documents and upload all relevant product-specific documents in FICS ahead of arrival for pre-arrival scrutiny where possible.
Food Safety MediumAnalytical non-conformance during sampling/testing (e.g., contaminants outside applicable limits) can lead to clearance denial even when documentation is complete.Qualify suppliers with robust QC; ensure CoA is from an appropriate laboratory scope and matches the shipment batch; run pre-shipment verification testing for risk parameters relevant to the declared use.
FAQ
Is calcium gluconate recognized as a food additive in India, and what is its INS number?Yes. Calcium gluconate is listed in FSSAI’s food additive compendium as INS 578 and is identified with functions such as acidity regulator and firming agent. Actual permissibility depends on the intended food category and the limits/conditions specified in the applicable FSSAI standards.
What documents are typically required to import calcium gluconate for food use into India through FSSAI clearance?FSSAI’s Food Imports Manual lists core documents for food import applications, including Bill of Entry, Country of Origin Certificate, Bill of Lading, FSSAI Import License, Invoice, Packing List, Ingredient List, Product Label, and an End Use Declaration. A Certificate of Analysis is also a key product-specific document commonly used in the sampling/testing workflow.
What is the Codex/JECFA safety evaluation status for calcium gluconate (INS 578)?JECFA lists calcium gluconate (INS 578) with an ADI of “not specified” (as part of a group ADI for related gluconates). Codex GSFA also lists INS 578 with functional classes such as acidity regulator, firming agent, and sequestrant, with uses permitted under GMP in specified food categories.